1. What’s New in Military Health Law?
FOR THE MILITARY HEALTH LAW SYMPOSIUM
John A. Casciotti
DoD Office of General Counsel
September 2014

2. Military Health Law: Who’s Who. Hon. Stephen W. Preston Hon
Military Health Law: Who’s Who? Hon. Stephen W. Preston Hon. Jonathan Woodson, M.D General Counsel of DoD ASD for Health Affairs

3. Outline Military Health Law Network Refresher Whazup?
Big Issues in 2014 & 2015
Quality Assurance & Patient Safety
Budget & Sequestration
Psychological Health & Suicide Prevention
Whadayado?

4. Military Health Law Network Research Helper http://www. usuhs
Appropriations
HR 4870, DoD Appropriations Act 2015
Continuing Resolution
Clinical Laboratory Improvements Act
DoDI , “Clinical Laboratory Improvement Program (CLIP),” 5/29/14
Detainee Health Care
DoDI E, Medical Program Support for Detainee Operations, 6/6/06
Disability Evaluation System

5. DoD Budget Proposals FY 15
Consolidated TRICARE Health Plan
Replacing triple option
Copays higher than Prime, but less than Standard
Freedom of choice of provider
Save $3.9B FY15-19
“TRICARE for Life” Enrollment Fee
Pharmacy Copay Increases
From current $5/17/34 & $0/13/43 phase to 2024: $14/45/XX and $14/45/90
SASC bill includes

6. More Potential Budget Issues
Rx refills for chronic conditions out of retail
TFL now; Other retirees 2015
U.S. Family Health Plan
GAO recommends termination
Military Compensation & Retirement Modernization Commission
Recommendations 2/1/15
Return of sequestration?
6.6% reduction in FY-16 from FY-15 level

7. Clinical Investigations Program
DoDI , “Defense Health Program Funding and Administration of Research and Clinical Investigation Programs,” 1/22/14
Requires Management Controls to ensure:
(1) Acceptance of non-federal support will be well documented and transparent and avoid the appearance of impropriety.
(2) Can’t accept any compensation from any non-federal source for duties within the scope of the CIP. Includes off-duty employment in connection with a CI activity.
(3) Can’t accept honoraria in connection with a CI activity or direct honoraria to third parties.
(4) Can’t direct use of funds of a non-federal entity except as specifically provided by approved agreement.

8. Disability Evaluation System
DoDI & DoDM “Disability Evaluation System (DES),” 8/5/14
Vol. 1: General
Information &
Legacy DES
Time Standards
PEBLO ratio 1:34
Vol. 2: Integrated
DES
Codification &
housekeeping

9. . . . MHLN Research Helper . . . Emergency Health Powers
DoDI , “Public Health Emergency Management within DoD,” 3/5/10, Ch. 6/1/12
Health Promotion
DoDI , “Health Promotion and Disease Prevention,” 4/28/14
Medical Readiness
DoDI , “Individual Medical Readiness,” 6/9/14
Medical Marijuana
ASD(R&FM) memo 2/4/13 reaffirms federal policy

10. MHS Governance: DHA Pubs
Defense Health Agency
INSTRUCTION
DRAFT NUMBER
[Date]
SUBJECT: Publication System Program
References: See Enclosure 1
1. PURPOSE. This Instruction:
a. In accordance with Deputy Secretary of Defense Memorandum (Reference (a)) and pursuant to the authority in DoDDs and (References (b) and (c)), this instruction implements policy, assigns responsibilities and prescribes procedures for the development, coordination and publication of Defense Health Agency (DHA) Publications.
b. Establishes the DHA Publication Website on the unclassified DHA Intranet (.mil domain) and the Internet (public domain).
2. APPLICABILITY
a. OSD, the Military Departments (including the Coast Guard at all times, including when it is a service in the Department of Homeland Security by agreement with that Department), the Office of the Chairman of the Joint Chiefs of Staff (CJCS) and the Joint Staff, the Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies, the DoD Field Activities, and all other organizational entities within the DoD (referred to collectively in this instruction as the “DoD Components”).
b. The Commissioned Corps of the Public Health Service and the Commissioned Corps of the National Oceanic and Atmospheric Administration, under agreement with the Department of Health and Human Services.
c. In accordance with the authority in Reference (b), for assigned functions, approved DHA publications are binding on DoD Components.
DoDD , Defense Health Agency, 9/30/13
Director, DHA has authority to: . . .
Establish and maintain for functions assigned, a DHA publication system for regulations, instructions, and reference documents produced by the DHA
(1) The Director, DHA, must ensure that all OSD and DoD Components are given the opportunity to coordinate when such publication is written, changed, or revised.
(2) For assigned functions, approved DHA publications are binding on DoD Components.

11. Psychological Health: Command Directed Mental Health Evaluations
DoDI , Mental Health Evaluations of Members of the Military Services, 3/4/13
Implements NDAA-12, § 711: SECDEF to issue regs:
“to eliminate perceived stigma associated with mental health services, promoting the use on a basis comparable to the use of other services.”
§ 711 repealed § 546 of NDAA-93, which required elaborate procedures for CDMHEs
Keeps whistleblower protections, inpatient procedures
Stigma still major issue
DoDI , Command Notification to Dispel Stigma. 8/17/11

12. Psychological Health & Suicide
SASC Proposed NDAA-15, § 701
Requires “a person-to-person mental health assessment” annually for each member of a regular component and each member of the Selected Reserve
Purpose is to “identify mental health conditions” needing treatment
House-passed Proposed NDAA-15, § 701
For deployed personnel, person-to-person mental health assessment required every 180 days
DoDI , Integration of Behavioral Health Services into Patient-Centered Medical Home Primary Care & Other Primary Care Settings, 8/8/13

13. Psych Health: Whadayado?
Scenario: Mental health provider says to JAG: A guy’s commander called me. He had referred the guy to mental health but it wasn’t an order. He wants me to tell him about the guy. The guy is not a threat to self or others, but he has problems. I’m not sure I should say anything. What’s your advice? Choices:
Commander always has a need to know
Medical ethics require confidentiality
It depends

14. Note: Orange total in 2012 shows expected suicides based on the 2001-2011 trend.
Expected number of suicides was calculated by using a forecast model based on previous years year-to-date suicide counts.
Source: Mortality Surveillance Division, Armed Forces Medical Examiner (Contact: )

15. Suicide Prevention: Means Reduction
Privately owned firearms
USD(P&R) Memo, “Guidance for Commanders & Health Professionals on Reducing Access to Lethal Means Through Voluntary Storage of Privately-Owned Firearms,” 8/28/04
Encourage voluntary storage; no incentives/disincentives
Controlled Substances
DEA Final Rule, “Disposal of Controlled Substances,” 79 FR 53,520, 9/9/14: Accepted DoD request to allow registered MTF pharmacies to have collection receptacles
MHS will implement broadly

16. Quality Assurance/Patient Safety
NYT 6/29/14, p. 1
“The military lags behind many civilian hospital systems in protecting patients from harm.”
There is “an overall failure to make patient safety a top priority.”
: 239 unexpected deaths; only 100 RCAs
Featured several multi-million dollar OB malpractice cases

17. QA/PS (cont.) NYT 9/2/14, p.1
9 MTFs have ADPL < 10; Dr. Lucian Leape says “they should be outlawed.”
DoD Sentinel Event policy often not followed. “In fact, … last year, the government paid 21 military patients more than $500,000 each to settle malpractice claims, an indication of ‘significant harm.’ Yet, hospitals identified only three as sentinel events, a pattern that has persisted for years.”

18. NYT (continued)
MHS “has consistently had higher than expected rates of harm and complications” in maternity care & surgery
Data show several MHS medical centers have higher than expected surgical complications
“and some hospitals perform worse” than civilian benchmarks “in multiple safety categories,” some “over 2 times average”
One take-away message: MTF-specific performance data transparency is the new normal

19. Report to SECDEF Review of access, quality, patient safety
Includes external experts reviewing data & analysis
Comparisons to civilian benchmarks
Comparison to high performing civilian systems
600+ page report scheduled for publication 9/24/14

20. Sentinel Events: Whadayado?
Policy: “MTFs shall actively identify sentinel events that occur in their facilities, conduct a root cause analysis, and form a corrective action plan for each event. The results ... shall be promptly reported....”
Definition: “An unexpected occurrence involving death or serious physical or psychological injury or risk thereof. Serious injury specifically includes loss of limb or function Such events are called ‘sentinel’ because they signal the need for immediate investigation and response.”
“Military Health System Patient Safety Program: A Legal Foundation for Preventing Medical Errors”
Root cause analysis preventive, not punitive

21. Feres Doctrine In the Supreme Court of the United States
Rationale for Feres:
Workers Comp premise
Equity for all disabled members & survivors
Good order and discipline
Quality of care not based on tort litigation
Accountability not based on tort litigation
Defensive medicine would impair MHS mission
Ritchie v. U.S.
cert. denied 5/5/14
_______________No _____________
In the Supreme Court of the United States
_____________________________________
JONATHAN RITCHIE, PETITIONER v.
UNITED STATES OF AMERICA
______________
ON PETITION FOR A WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
BRIEF FOR THE UNITED STATES IN OPPOSITION
__________________________________________________

22. Quality Assurance Program: DoD 6025.13-M, Oct. 2013
Implement stat. changes to licensure portability
Adopt credentialing by proxy for telemental health
Revise § 1102 standards to increase transparency
Follow same “accountability process” for Feres-barred cases (i.e., disability) as for paid claim cases
Reinforce NPDB reporting w/in 180 days
Improve reporting of Sentinel Events
Establish patient opportunity to be heard
DoD-wide Healthcare Resolutions Program

23. Sexual Assault Prevention & Response
NDAA 14, § 1725(b):
At least 1 Sexual Assault Nurse Examiner (SANE) assigned to every MTF with 24/7 ED;
Other MTFs must make SANE services available (report language says in MTF)
SD sets training and certification requirements
DoDI , “Sexual Assault Prevention and Response Program Procedures,” 3/28/13
Encl. 7, Healthcare Provider Procedures

24. Transgender Issues
EO (7/21/14) amended prior EOs on Fed. employee (EO 11478) and Federal contractor (E.O ) nondiscrimination
Prohibits discrimination based on “gender identity”
For contractors, Sec-Labor shall do regulations within 90 days
HHS: gender discrimin. prohibition includes gender identity
VA now has Transgender Treatment Program
DoDI , “Medical Standards for Appointment, Enlistment, or Induction in the Military Services,” 4/28/10
DoDI , “Enlisted Administrative Separations,” 1/27/14
10 USC 1079: no TRICARE for gender change surgery
TRICARE regulation: gender dysphoria treatment not covered

25. Veterans Affairs Sharing
DTM , “Separation History and Physical Examination (SHPE),” 7/7/14
All members serving > 180 days get DoD or VA SHPE before separation; implements 10 USC §1145(a)(5)
SD Memo 6/23/14, Service Treatment Records to VA
Health Artifact & Image Management Solution (HAIMS) “taking too long”; take corrective action; 45 day goal
NDAA-14 § 525: STRs to VA = HIPAA allowed disclosure
Veterans Access, Choice, and Accountability Act of 2014
Expands VA services from non-VA providers (incl. DoD)
Approps. Act § 8061: don’t support agency >90 days in arrears without SD national security waiver

26. . . . MHLN Research Helper . . . Outpatient Food & Beverages
DoDI , “Food & Beverages to Certain Members & Dependents Not Receiving Inpatient Care at MTFs,” 3/7/14
Personal Services Contracts
DEA Registration rules same as for civilian employees
Suicide Prevention
DoDD , “Defense Suicide Prevention Program,” 6/18/13
Wounded Warriors
DTM , “Interim Guidance on Personal Acceptance of Gifts from Outside Sources for Combat-Related or Similar Injuries or Illnesses,” 4/17/14
DoD-VA MOU Interagency Complex Care Coordination, 7/29/14

27. QUESTIONS? RECAP: Whadayado?
Patient Safety: Do Sentinel Event RCAs
Psych Health: Reduce stigma
Budget: Follow the money
QUESTIONS?